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FiberTak Suture Anchor

by Arthrex, Inc.

510(k) K230568

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK230568 Date1 Apr 2023ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
MBI
Device class
Class II
Regulation
21 CFR Part 888.3040
Advisory committee
Orthopedic
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 22 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The FiberTak Suture Anchor is a soft anchor device available in single and double-loaded configurations with various suture options. It is designed for soft-tissue repair procedures and is complemented by curved and straight guide delivery systems along with 1.6 mm to 1.8 mm drills to minimize bone removal.

This device is supplied in sterile packaging and is intended for single-use. It is MRI safe and has received FDA 510(k) clearance with the product code MBI. The FiberTak Suture Anchor is available in multiple sizes and is authorized for use in orthopedic procedures.

Other devices from Arthrex, Inc.

See all devices from Arthrex, Inc. →

Questions

AI-generated answers, 22 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the FiberTak Suture Anchor used for?

    The FiberTak Suture Anchor is designed specifically for soft-tissue repair procedures in orthopedic applications. It comes in single and double-loaded configurations with various suture options to accommodate different surgical needs.

  • How is the FiberTak Suture Anchor supplied and is it reusable?

    The FiberTak Suture Anchor is supplied in sterile packaging and is intended for single-use only. It should not be reused or resterilized as this could compromise its integrity and safety.

  • What sizes and configurations are available for the FiberTak Suture Anchor?

    The FiberTak Suture Anchor is available in multiple sizes and comes in both single and double-loaded configurations. It is complemented by curved and straight guide delivery systems along with 1.6 mm to 1.8 mm drills to minimize bone removal during procedures.

  • Is the FiberTak Suture Anchor MRI safe?

    Yes, the FiberTak Suture Anchor is MRI safe, meaning it can be safely used in patients undergoing MRI procedures without causing image artifacts or safety concerns.

  • What is the regulatory status of the FiberTak Suture Anchor?

    The FiberTak Suture Anchor has received FDA 510(k) clearance with the product code MBI. It is classified as substantially equivalent to predicate devices and is authorized for use in orthopedic procedures.